Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Director, Clinical Leader - Retina to be located in Raritan, NJ . Remote work options may be considered on a case-by-case basis and if approved by the Company.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC. discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo .
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The incumbent will serve as a Clinical Leader in the Cardiovascular/Metabolism/Pulmonary Hypertension & Retina (CVMPH & R), with a focus on drug development for retinal projects. The initial effort will be towards a first-in-class gene therapy program for age-related macular degeneration, a prevalent and blinding condition.
The Sr. Director will have broad responsibilities including:
- Provides active medical and scientific contribution to a matrixed cross-functional Compound Development Team and the Clinical Team. Team matrix interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business-related disciplines.
- Provide strategic, clinical, and scientific support through all phases of clinical development
- Accountable for implementation of the Clinical Development Plan
- Working with functional partners responsible for the clinical development strategy for the assigned development program(s)
- Providing leadership on managing/addressing specific project/program-related issues and presenting to and negotiating with the CVMR and Janssen leadership teams on development plans or program-related issues
- Working with Global Clinical Operations (GCO), Regulatory, and Global Medical Safety, leads the clinical team in responding to medical and compound-related issues
- Working with Regulatory Affairs and GCO with regard to responses to questions from Health Authorities and IRBs/ECs
- Leading the clinical team, responsible for the timely completion, content, and quality of key deliverables including protocols, reports and submissions to health agencies
- Supervising and contributing to the timely completion and quality of clinical study reports, including providing key input to statistical analysis plans and the interpretation of statistical analyses
- Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations
- Provides key input into diligence activities
- Participates or leads cross-departmental or cross-functional projects with broad Janssen impact.
- Builds credible relationships with opinion leaders and may act as company spokesperson regarding publication of research findings and presentations to relevant health authorities and consultant/advisory meetings.